Empagliflozin add-on to Insulin in Type 1 Diabetes Mellitus Over 28 Days

Status Completed

Clinical Trial Summary

Placebo-controlled, double blind (triple-dummy technique), randomised parallel design comparison of three oral doses (2.5 mg, 10 mg, and 25 mg) of empagliflozin in patients with T1DM as adjunctive therapy to insulin over 28 days. Patients will undergo a 14-day open-label placebo run-in period before randomisation. Background insulin therapy will be kept stable during the first 7 days of the treatment period and will be freely adjusted thereafter.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01969747
Study type	Interventional
Source	Boehringer Ingelheim
Contact
Status	Completed
Phase	Phase 2
Start date	November 2013
Completion date	April 2014

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